Healthcare Facilities & Services

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Trovagene Inc expands clinical program with new study evaluating its precision cancer monitoring platform in lung cancer

Monday, 29 Sep 2014 08:05am EDT

Trovagene Inc:Says it has expanded its clinical program to include a study designed to evaluate use of its precision cancer monitoring technology in the management of lung cancer patients.Says primary objective of the study is to detect and monitor EGFR mutations in urine, plasma and tissue to determine concordance.Says Secondary objectives include correlating quantitative EGFR mutational load over time with tumor burden, and demonstrating detection of the resistant EGFR T790M mutation prior to clinical or radiographic progression in lung cancer patients treated with tyrosine kinase inhibitor therapy.Says about 225 patients are anticipated to be enrolled in the study.

iMedicor Inc launches proprietary iCoreDental, Cloud-Based, customizable electronic health records platform

Tuesday, 5 Aug 2014 10:17am EDT

iMedicor Inc:Launches second cloud-based software product one week following the launch of iCoreMD.iCoreDental is a fully customizable, cloud-based, Electronic Heath Record (EHR) system for dentists.

CombiMatrix Corp 's Pediatric development disorders analysis test granted conditional approval from New York State Department of Health

Tuesday, 15 Jul 2014 08:00am EDT

CombiMatrix Corp:Says its chromosomal microarray analysis (CMA) test to identify development disorders in pediatric patients, the CombiSNP Array for Pediatric Analysis, has received conditional approval from the New York Department of Health for testing on patient samples.CMA testing for pediatric development disorders, such as its CombiSNP CMA test, is recommended by the American College of Medical Genetics for individuals with developmental delays, birth defects, physical deformities or autism or autism spectrum disorder.Under conditional approval, CombiMatrix will be able to market the test in New York while the test is under Clinical Laboratory Reference System review.Upon completion of the review, either the test will receive full marketing approval or additional information will be required in order to achieve final approval.

Signal Genetics Inc obtains New York State approval for MyPRS Multiple Myeloma Prognostic Test

Monday, 30 Jun 2014 08:30am EDT

Signal Genetics Inc:New York State Department of Health approval of its MyPRS (Myeloma Prognostic Risk Signature) test.MyPRS is a microarray-based gene expression profiling assay used to assist in treatment planning and disease management of patients with multiple myeloma and related disorders.By profiling genomes of patients' isolated plasma cells, MyPRS generates a personalized prognostic score and molecular subtype that may inform each patient's specific therapeutic alternatives.Extensive clinical trials and international peer-reviewed studies reinforce the clinical validity and utility and prognostic performance of the test.

Enzo Biochem receives U.S. patent on more efficient vector for use in gene therapy

Friday, 6 Jun 2014 08:30am EDT

Enzo Biochem Inc:Assigned U.S. Patent Office Patent No. 8,742,090, related to the construct of an artificial vector capable of greater efficiency, in general, in targeting specific cells in the application of gene therapy and gene transfer technology.

S H L Telemedicine Ltd receives the China Food and Drug Administration for marketing of smartheartTM in China

Wednesday, 14 May 2014 01:00am EDT

S H L Telemedicine Ltd:Says it has received the China Food and Drug Administration (CFDA) approval for the marketing of the smartheartTM in China.The smartheartTM has already received marketing approvals in Europe, the U.S. and Japan.

Cancer Genetics inc launches genomic tests for Follicular Lymphoma and Mantle Cell Lymphoma

Monday, 5 May 2014 08:00am EDT

Cancer Genetics Inc:Received CLIA and New York state approvals for clinical use of its proprietary mature B-cell neoplasm array, or MatBA for Follicular Lymphoma and Mantle-Cell Lymphoma.Both tests further extend portfolio in hematologic cancers being developed by CGI and both were developed and validated via a research collaboration with Memorial Sloan-Kettering Cancer Center.Understanding potential outcome for patient is critical in making informed choices about treatment selection, clinical trial involvement and patient management.

Interleukin Genetics Inc secures approval in New York State to offer PerioPredict

Tuesday, 22 Apr 2014 07:00am EDT

Interleukin Genetics Inc:Receives conditional approval from New York State Department of Health to offer, process and report results of PerioPredict Genetic Risk Test for periodontal disease.State of New York is the only U.S. state that requires an independent regulatory review process including technical validation with clinical utility for laboratory developed tests run within a CLIA certified laboratory.As result of New York State approval the PerioPredict test is available to dental providers and their patients in all 50 U.S. states.

TrovaGene presents Clinical data of molecular diagnostic platform to non-invasively track cancer patients' response to therapy

Tuesday, 8 Apr 2014 11:00am EDT

Trovagene Inc:Demonstrate ability of Trovagene's molecular diagnostic platform to detect and monitor BRAF V600E mutations in cancer patients.Says BRAF V600E oncogene mutation assay was able to identify mutation in 29 patients (88 pct) at any time point during study, demonstrating high level of concordance with tissue biopsy.Says 25 of the 33 patients (76 pct) were positively identified for the mutation with their first urine sample.Longitudinal analysis was performed in 17 patients who had more than one urine-based test during the monitoring period.Of these patients, 13 (76 pct) showed correlation between response to treatment and mutational status observed by urine-based test.

Quest Diagnostics Inc's focus diagnostics receives FDA clearance for moderate complexity simplexa HSV 1 & 2 Direct molecular test for aiding the diagnosis of encephalitis

Monday, 24 Mar 2014 09:12am EDT

Quest Diagnostics Inc:Says its focus diagnostics products business has received expedited FDA 510(k) clearance and CLIA moderate complexity categorization for its new Simplexa HSV 1 & 2 Direct molecular test on the 3M Integrated Cycler.Encephalitis is an inflammation of the brain often caused by the herpes simplex or other viruses.


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